1. Authorisation Number

:

SE-H-WDA-24-004894

2. Name of Authorisation Holder

:

Orifarm Generics AB

(ORG-100005764 / LOC-100086883)

3. Address(es) of Site(s)

:

Klara Sodra Kyrkogata 1, Stockholms Domkyrkofors., Stockholm, 111 52, Sweden 

3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)

:

Secondary business name: Orifarm Healthcare 

4. Legally registered address of Authorisation Holder

:

P. O. Box 56048, Stockholm, 102 17, Sweden

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:

9. Date

:

2024-09-02

10. Annexes attached

:

Annex 1 Scope of wholesale distribution authorisation

Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number

Annex 3 (Optional) Name(s) of responsible person(s)

Annex 4 (Optional) Date of Inspection on which authorisation was granted

Annex 5 (Optional) Additional provisions based on national requirements

Name and address of the site: Orifarm Generics AB

(ORG-100005764 / LOC-100088966)

, Klara Sodra Kyrkogata 1, Stockholms Domkyrkofors., Stockholm, 111 52, Sweden   

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Secondary business name: Orifarm Healthcare

Human medicinal products

Reason for Withdrawing:

Replaced by authorisation number SE-H-WDA-24-004894, issue date 2025-01-18.

Union Format for a Wholesale Distribution Authorisation

SE-H-WDA-24-004894

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